Is this your brand? Sign in to claim ownership.

Kulzer, Inc.

Last updated September 17, 2026

What Kulzer, Inc. makes

Kulzer, Inc. manufactures dental materials including resin artificial teeth, dental composite resins, veneer resins for prostheses, polyether impression materials, and laboratory CAD/CAM dental milling systems. Their portfolio also includes dentine bonding agents and specialized dental resins for restorative and prosthetic applications.

The company’s products are classified as Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. Kulzer, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Kulzer, Inc. manufacture?

Kulzer, Inc. specializes in dental materials and systems. Their portfolio includes resin artificial teeth, dental composite resins, veneer resins for dental prostheses, polyether impression materials for dental impressions, and laboratory CAD/CAM dental milling systems. They also produce dentine bonding agents and specialized resins for restorative and prosthetic dental applications, all designed for use in dental procedures.

Where is Kulzer, Inc. based?

Kulzer, Inc. is headquartered in the United States. The company focuses on developing and manufacturing dental materials and systems primarily for use in clinical and laboratory settings.

Which regulatory registries list Kulzer, Inc.’s devices?

Kulzer, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

How are Kulzer, Inc.’s devices classified under medical device regulations?

Kulzer, Inc.’s devices fall under Class II medical device classification. This classification applies to products that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as dental materials and systems used in restorative or prosthetic procedures.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 4315 S. Lafayette Blvd., SOUTH BEND, IN, 46614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1821514
DUNS Number: —

Catalogue (6131)

Page 68 of 123

Device	Model / Reference	Registries	Class	Status
Signum composite	66020025	FDA UDI	Class II	Active
Mondial 8i, D2 / 33 U, CE	66973906	FDA UDI	Class II	Active
Premium 6, B4 / S2, CE	66007099	FDA UDI	Class II	Unknown
Mondial 8i, A1 / 31 U, CE	66973784	FDA UDI	Class II	Active
Artic	66080334	FDA UDI	Class II	Active
Artic 8, D3 / 30 degree - 30 L, CE	66037080	FDA UDI	Class II	Active
Mondial 6, A3 / O457, CE	66016911	FDA UDI	Class II	Active
Delara	66071522	FDA UDI	Class II	Active
Artic 6, C1 / S 20, CE	66013977	FDA UDI	Class II	Active
Signum composite flow	66051713	FDA UDI	Class II	Active
Premium 8, D2 / SL, CE	66007280	FDA UDI	Class II	Unknown
Delara	66071457	FDA UDI	Class II	Active
Delara	66071619	FDA UDI	Class II	Active
Artic	66080323	FDA UDI	Class II	Active
Delara	66071447	FDA UDI	Class II	Active
Delara	66071609	FDA UDI	Class II	Active
Delara	66071285	FDA UDI	Class II	Active
Premium 6, C2 / L20, CE	66006971	FDA UDI	Class II	Unknown
Basic 8, B1 / CU, CE	56739454	FDA UDI	Class II	Unknown
Delara	66071383	FDA UDI	Class II	Active
Signum matrix	66019705	FDA UDI	Class II	Active
Artic 8, B3 / 30 degree - 34 L, CE	66037042	FDA UDI	Class II	Active
Mondial 8, D3 / 37L, CE	66017440	FDA UDI	Class II	Active
Delara	66071403	FDA UDI	Class II	Active
Delara	66071241	FDA UDI	Class II	Active
Artic	66080330	FDA UDI	Class II	Active
Artic 6, D2 / R 30, CE	66015053	FDA UDI	Class II	Active
Artic 8, C3 / 10 degree - 32 U, CE	66015215	FDA UDI	Class II	Active
Premium 6, C1 / S6, CE	66007132	FDA UDI	Class II	Unknown
Premium 8, C2 / LL, CE	66007213	FDA UDI	Class II	Unknown
Basic 8, B1 / BO, CE	56739406	FDA UDI	Class II	Unknown
Basic 6, A2 / L02, CE	56739082	FDA UDI	Class II	Unknown
Premium 8, BL2 / ML, CE	66802997	FDA UDI	Class II	Unknown
Mondial 8, BL3 / 32L, CE	66802217	FDA UDI	Class II	Active
Mondial 6 DS, A3 / T452, CE	66985664	FDA UDI	Class II	Unknown
Basic 6, A3 / U04, CE	56739291	FDA UDI	Class II	Unknown
Artic 8, C1 / 20 degree - 32 L, CE	66014148	FDA UDI	Class II	Active
Artic 8, B4 / 20 degree - 34 L, CE	66014165	FDA UDI	Class II	Active
Mondial 6i, A4 / T2, CE	66970550	FDA UDI	Class II	Active
Premium 6, C4 / R4, CE	66007071	FDA UDI	Class II	Unknown
Mondial 6, BL2 / L373, CE	66801043	FDA UDI	Class II	Active
Mondial 8, A2 / 30L, CE	66802113	FDA UDI	Class II	Active
Artic 8, A2 / 20 degree - 32 U, CE	66012946	FDA UDI	Class II	Active
Artic 6, B1 / T 40, CE	66012865	FDA UDI	Class II	Active
Premium 8, C2 / XS, CE	66007293	FDA UDI	Class II	Unknown
Pala	66077539	FDA UDI	Class I	Active
VENUS DIAMOND SYRINGE REFILL 1x4G A4	66035476	FDA UDI	Class II	Active
Artic 6, B4 / S 10, CE	66013967	FDA UDI	Class II	Active
Mondial 6, A3.5 / S453, CE	66016944	FDA UDI	Class II	Active
Artic digital 6, B4 / R20D, CE	66983089	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (2)

Establishments registered with the FDA under this company group, matched by name.

Kulzer Gmbh HANAU Hesse · DE FEI 3005665377
Kulzer SRL Sacalaz-Judet Timis · RO FEI 3011203516